Anticoagulant antagonist in phase 2 development shelved

A biotechnology company that specializes in acute care therapeutics has shelved its development of an […]

A biotechnology company that specializes in acute care therapeutics has shelved its development of an anticoagulant therapeutic designed to neutralize the effects of blood thinner heparin in certain situations because participants in two clinical trials experienced drops in blood pressure.

PolyMedix (OTCBB:PYMX.OB) stopped enrollment in a phase 2 clinical trial for reversing the anticoagulant activity of unfractionated heparin in patients who undergo percutaneous cardiac procedures. It also halted recruitment for a phase 1B/2 clinical trial for reversing the anticoagulant activity of the low molecular weight heparin enoxaparin in healthy volunteers.  

Unfractionated heparin has to be given intravenously because it’s only effective for a short amount of time, but low molecular weight heparin can be taken in pill form because it has a longer biological half life.

PolyMedix is looking for a strategic partner to move the heparin antagonist forward.

In a statement commenting on the shelving of the anticoagulant antagonist, the Radnor, Pennsylvania company suggested ways other companies could deal with the blood pressure issues like delivering the therapeutic over longer infusion times and by making formulation volume modifications.

The move leaves the company with its antibiotic therapeutic in phase 2 development as it faces down a $94.6 million deficit.

Its antibiotic therapeutic is classified as a defensin-mimetic, a synthetic chemical mimic of host defense proteins, one of the oldest antimicrobial defense systems found in most living creatures, according to a company statement.

The intravenous antibiotic is initially being tested to treat acute bacterial skin and skin structure infections caused by drug-susceptible and drug-resistant strains of staphylococcus aureus bacteria.  It got positive results in a randomized, blinded, active-controlled multinational phase 2 clinical trial conducted in Canada, Russia and Ukraine. But a phase 2B trial set to begin later this year through 2013 is expected to cost $4 million to $6 million. And it will need additional funds to advance the antibiotic through its submission of a new drug application, or NDA.

It is also being developed to treat bloodstream infections and lung infections, according to its drug pipeline.

Although the company has been able to secure at least $12 million in loans from Mid-Cap Financial, it faces some challenges ahead. Big Pharma companies like GlaxoSmithKline, Bayer, Merck and Pfizer have dominated the antibiotics market with plenty of smaller companies developing novel approaches for more potent antibiotics to more effectively combat drug-resistant bacterial strains, according to the risk factor section of its U.S. Securities and Exchange Commission filing.

As for therapeutics that neutralize the effects of heparin during cardiac surgery, protamine has dominated and it may prove difficult for a strategic partner to find a niche for PolyMedix’s alternative.
The company will focus its development efforts on more advanced clinical trials and investigating broader potential uses for the antibiotic therapeutic PMX-30063 and other defensin-mimetics.

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